Opioid Use DisorderFORWARDNCT06001437
Following Outcomes Remotely Within Addiction Recovery Domains
An observational study of Opioid Use Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults with opioid use disorder who have previously participated in one of two applicable opioid use disorder clinical trials in the NIDA Clinical Trials Network.
Who may be able to join
- Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial.
- Be willing and able to provide locator information for survey distribution (mobile number and/or email address).
- Be willing to allow the linkage of prior clinical trial study data to the current study record.
Who cannot join
- Unable to understand or communicate to complete consent or study assessments.
- Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
- Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains
The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.
Read the detailed description
This is a longitudinal follow-up study that will collect yearly outcomes data on adults with opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA Clinical Trials Network. This longitudinal, observational study will entail annual phone and online assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via text messaging and email to be completed electronically by the participant. No participant randomization will occur for this study, and study data will be considered observational in nature. We aim to characterize the long-term course of OUD and to evaluate the long-term course and recovery of OUD.
- Conditions
- Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use
Count of months of opioid use.
Measured: 12 months
Engagement in Treatment
Count of months engaged in treatment for opioid use disorder
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Sep 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, McHugh, R. Kathryn, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001437
- Sponsor's protocol ID
- 2023P000766
- Other IDs
- 3UG1DA015831-21S4
- Acronym
- FORWARD
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains
- ClinicalTrials.gov ID
- NCT06001437
- Acronym / sponsor ID
- FORWARD / 2023P000766
- Conditions
- Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.
Detailed description
This is a longitudinal follow-up study that will collect yearly outcomes data on adults with opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA Clinical Trials Network. This longitudinal, observational study will entail annual phone and online assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via text messaging and email to be completed electronically by the participant. No participant randomization will occur for this study, and study data will be considered observational in nature. We aim to characterize the long-term course of OUD and to evaluate the long-term course and recovery of OUD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with opioid use disorder who have previously participated in one of two applicable opioid use disorder clinical trials in the NIDA Clinical Trials Network.
Key inclusion criteria (3 listed)
- Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial.
- Be willing and able to provide locator information for survey distribution (mobile number and/or email address).
- Be willing to allow the linkage of prior clinical trial study data to the current study record.
Key exclusion criteria (3 listed)
- Unable to understand or communicate to complete consent or study assessments.
- Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
- Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid Use
Time frame: 12 months
Count of months of opioid use.
Engagement in Treatment
Time frame: 12 months
Count of months engaged in treatment for opioid use disorder
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.